Telescopic Dissection vs. Balloon Dissection During Laparoscopic TEP Inguinal Hernia Repair

Minimally invasive approaches have been successfully incorporated into the surgical
armamentarium of inguinal hernia repair, with proven benefits for decreased postoperative
pain and earlier return to work. Laparoscopic inguinal hernia repair is more commonly
performed through the transabdominal preperitoneal (TAPP) approach or the totally
extraperitoneal (TEP) approach. The TEP approach has been proven to have equivalent
recurrence rates, decreased postoperative pain, earlier ambulation and return to work when
compared to the open, tension-free repairs. Additionally, when compared to TAPP, the TEP
approach has also been associated with decreased postoperative pain, shorter operative times
and equivalent rates of postoperative complications and hernia recurrence.

A key step in the TEP procedure is the creation of the extraperitoneal space, which can be
performed by two different techniques: telescopic dissection or balloon dissection.Telescopic
dissection is the creation of the extraperitoneal space with blunt dissection performed with
the laparoscopic probe. Telescopic dissection was initially described in the original paper
describing the TEP procedure, in 1992 by Ferzli et al. To date, telescopic dissection is
still used in many centers around the globe. In order to facilitate the creation of the
initial working space, disposable dissection balloons have been developed and are
commercially available. Balloon dissection is now the most commonly used method for creation
of the extraperitoneal space for TEP procedure in the United States. A randomized,
prospective multicenter study conducted between 1994 and 1997 and published in 2001 by
Bringmam and colleagues has compared operative times, conversion rates, postoperative
morbidity and time to return to work between patients in which the TEP procedure was
performed with or without the balloon dissector. In this study, the use of the balloon was
associated with lower conversion rates and statistically, but perhaps not clinically,
significantly shorter operative times (9 minutes difference). No difference was seen in
postoperative morbidity, recurrence rates or time to return to work between the groups. Of
note, the surgeons performing these procedures were still at an early point of their learning
curve for the TEP procedure, which might have influenced the results, especially for the
group without the balloon.

Low-cost alternatives have been proposed to substitute the commercially available balloon
dissector, especially in developing countries where the access to the balloon dissector is
restricted. Despite the fact that the TEP procedure has become more popular in the last 15
years, with surgeons being each time more proficient in this operation, there is a paucity of
data comparing cost and surgical outcomes among telescopic and balloon dissection.

Furthermore, according to current consensus, the use of a balloon dissector is especially
recommended during the learning period when surgeons are still unfamiliar with the
preperitoneal anatomy. Especially for expert surgeons, delineation of the inguinal area and
dissection in the creation of extraperitoneal space can be performed as safe and efficient
with telescopic dissection.

The investigator's institution has in its staff, three expert surgeons, with a robust
experience in the TEP procedure, performed either telescopic or balloon dissection. To help
determine if the use of the balloon dissector is associated with a significant decrease in
operative times when compared to telescopic dissection, the investigators aim to conduct a
randomized controlled trial using the Americas Hernia Society Quality Collaborative (AHSQC)
registry. The AHSQC is a nationwide registry designed to improve the value of hernia care
using real-time continuous quality improvement principles. Data pertaining to baseline and
intraoperative variables, short and long term outcomes are collected prospectively for
quality improvement purposes. The information collected in the AHSQC offers a natural
repository of information that can be used for research, in addition to its quality
improvement purpose.

The investigators hypothesize that at their institution, during TEP repairs, telescopic
dissection will be associated with a 15-minute increase in total operative times for a
unilateral inguinal hernia, when compared to the balloon dissection.

Specific Aim #1: To determine if the use of a balloon dissector by an experienced surgeon is
associated with a significant decrease in total operative time compared to telescopic
dissection for the creation of the extraperitoneal space during laparoscopic TEP inguinal
hernia repair Specific Aim #2: To determine if there is a difference in postoperative pain
scores at 1 day, 7 days and 30 days postoperatively between patients who have undergone
laparoscopic TEP inguinal hernia repair performed either with telescopic dissection or
balloon dissection.

Specific Aim #3: To determine if there is a difference in the rate of intraoperative
complications and 30-day wound events between patients who have undergone laparoscopic TEP
inguinal hernia repair performed either with telescopic dissection or balloon dissection.

Specific Aim #4: To determine if 1-year hernia recurrence rates differ between patients who
have undergone laparoscopic TEP inguinal hernia repair performed either with telescopic
dissection or balloon dissection.

Inclusion Criteria:

- 18 years of age or older

- Able to give informed consent

- Unilateral inguinal hernia

- Scheduled for elective inguinal hernia repair

- Eligible to tolerate general anesthesia

- Eligible to undergo minimally invasive inguinal hernia repair

- Willing to undergo mesh-based repair

Exclusion Criteria:

- Younger than 18 years old

- Unable to give informed consent

- Bilateral Inguinal hernias

- Emergent inguinal hernia repairs ( acute incarceration or strangulation)

- Recurrent inguinal hernia with prior preperitoneal mesh

- Unable to tolerate general anesthesia

- Not eligible for minimally invasive inguinal hernia repair

- Not willing to undergo mesh-based repair